A Lago Vista woman who had a double mastectomy and her ovaries removed four years ago after learning she had a gene mutation that greatly increased her cancer risk was celebrating a potentially landmark court victory Monday against the company that did her test.
Genae Girard, who was 36 and childless when she was tested, wanted a second opinion before deciding to proceed with those life-altering surgeries. But she couldn’t get one, she said, because Myriad Genetics of Salt Lake City owned the patent to her gene mutation. She, along with other patients, scientists and the American Civil Liberties Union sued Myriad and the U.S. Patent and Trademark Office last year, saying the company’s ownership of two gene mutations restricted patients’ access to medical care and scientists’ ability to do research.
In New York on Monday, U.S. District Judge Robert Sweet ruled in favor of Girard and the other plaintiffs. Sweet also released the patent office as a defendant from the suit at the government’s request.
Chris Hansen, one of the lawyers who argued the case for the ACLU, said the ruling provides a “strong advance for women’s health and for science.”
He said the ruling, if upheld, would threaten many of the patents held on about 20 percent of the human genome.
“In our view, it would enormously increase women’s opportunities to receive testing and diagnoses and would liberate research opportunities for researchers all over the country,” Hansen said.
Girard, now 40 and CEO of Corporate Culture Consulting LLC, said human error can occur when only one company has access to a person’s genetic information. She said she was “pretty scared (that) so much was riding on one test.”
“I believe (the ruling) is going to change decision-making for all women” who get a positive genetic test for the mutation, Girard said. “They’re going to have the ability to get validity on the test by getting it run by multiple companies. They can get a second opinion now.”
A statement by the ACLU says the decision, which could be appealed by the company and end up before the U.S. Supreme Court, “marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes.”
Sweet said he invalidated the patents because DNA’s existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body nor the information it encodes.
The judge said his findings were consistent with Supreme Court rulings that have established that purifying a product of nature does not mean it can be patented.
He said the company deserved praise for what is “unquestionably a valuable scientific achievement,” but not a patent because the “isolated DNA is not markedly different from native DNA as it exists in nature.”
—From Cox Newspapers staff reports